Transcript Status October 2002 Pipeline

This is MEDIVIR
• OUR research is based on the know how of proteases and
polymerases. The aim is to have a steady flow of CDs into clinical
development.
• WE focus on mainly two therapeutic areas; infectious and
immunological diseases.
• OUR pipeline is balancing commercial opportunities and development
risks.
• WE are one of the largest biotech companies in Europe in terms of
pipeline and employees, located in Cambridge (UK) and Huddinge
(SE).
• WE own CCS, a specialty pharma company.
• Most likely to have one product to launch in 2005.
Proteases and polymerases represent
major pharmaceutical opportunities
Medivir has a broad know how in these
enzymes, enabling a variety of research options
and still be focused.
Pre-clinical Discovery in Medivir
Infectious and immunological diseases
Target
Identification
Hit
Identification
Lead
Identification
Lead
Optimisation
CD
Nomination
CD
IND
RAPiDTM FOCUSTM
- polymerases
Identification
RAPiDTM
Protease & polymerase
FOCUSTM
compound libraries
Screening
Validation
Identification
- protease gene family

Prodrugs
Robust
Leads
Hits
X-ray
Structure
XED
SBDD
Combinatorial
Chemistry
DMPK
Improved capacity and shorter time to CD
CD = Candidate Drug
IND = Investigational New Drug
SBDD = Structured Based Drug Design
NNRTI = Non Nucleoside Reverse
Transcriptase Inhibitor
PI = Protease Inhibitor
CD
High activity in operations
2002-09-30:
Positive results for Medivir’s HIV and hepatitis B antiviral MIV-210 presented at ICAAC.
2002-09-10:
Change of CEO at Medivir
2002-05-31:
A phase IIa clinical study with Medivir’s compound MIV-310 shows a major antiviral effect
in patients with multi drug resistant HIV.
2002-05-29:
Proof of principle in research on treatment of multiple sclerosis (MS).
2002-04-25:
Change in the Medivir HIV program.
2002-04-15:
Medivir signs agreement to out-license its novel HIV/AIDS treatment to Roche.
2002-02-26:
Medivir and Reliant Pharmaceuticals form strategic alliance.
2001-12-20:
Medivir and Peptimmune announce break-trough research on treatment of rheumatoid
arthritis.
2001-12-06:
Medivir’s HIV research programme designates Candidate Drug.
Status October 2002
Partnership and deal values
Partnership and deal values
• Deal values for existing partnerships amounts to SEK 700 million (refers to 3 deals) of
which SEK 100 million is down payments to be accounted as revenues during 2002.
• Cash wise, Medivir has received SEK 80 million of these during H1 2002.
• Medivir has retained the Nordic marketing rights for RP-606 and MV026048.
Corporate
• Peptimmune 50/50 ”joint venture” for Cathepsin S in late pre-clinical research.
• Chiron for Hepatitis C in pre-clinical discovery.
• Roche for HIV-NNRTI in late pre-clinical development.
• Reliant in RP-606 (Shingles) on its way to phase III.
University
• University of Dundee – AEP, autoimmune disorders, in early pre-clinical discovery.
• St:George (London, UK) – Cathepsin K, osteoporosis, in pre-clinical lead
identification phase.
• MRC (London, UK) – broad anti-bacterial program, in early pre-clinical discovery.
• Karolinska Institute – Alzheimer disease, in pre-clinical discovery.
• Agrivir – Joint venture med BioAgri.
• And several other universities in Sweden, US and UK.
Status October 2002
Financial
The group, period ending 30 June
• Profit after financial items amounted to SEK 4,3 (-68,0) million.
• Cash SEK 195 million.
• Going forward, the R&D expenditure will be in the range of 150160 MSEK on a rolling 12 month average.
CCS, a strategic and financial asset to Medivir
• Net sales SEK 76,7 (63,8) million during H1 (2002); SEK 9,7
(9,7) million profit. Cash positive operations.
• CCS had extraordinary costs amounting to MSEK 4,5 during H1
(2002) for investments for the coming AstraZeneca production.
• Significant increase in sales, profit and “market cap” predicted
over next years from both internal activities and by aggressive
acquisition strategy.
Status October 2002
Pipeline
• Varity of projects focusing on; HIV, Hepatitis, Cold sores,
Shingles, MS, RA and Osteoporosis of which;
» 4 projects in clinical development
» 4 late stage pre-clinical projects
» More than 10 discovery activities
MEDIVIR’S PROJECT PORTFOLIO
Explorative
phase
Lead
Identification
Optimization
phase
Late preclinical
phase
Cathepsin K1
Osteoporosis
Cathepsin S1
Autoimmune
diseases
MV0260482
HIV
Early
Projects
More
than
10
activities
HIV1
Phase I
MIV-2102
Hepatitis
Phase II
Phase III
RP-6062
Shingles
ME-6093
Oral herpes
MIV-3102
HIV
1 Protease inhibitor
2 Polymerase inhibitor
3 Polymerase inhibitor combination
Completed, on its way into next step
The figure above schematically depicts the current development phase for the various Medivir projects.
Status clinical projects
• RP-606 - Shingles: Licensed to reliant in February. Transfer of project
completed in May. Planning and development work ongoing towards
phase III studies. Waiting for the end of phase II meeting with FDA.
• ME-609 - Cold sores: Seeking partnership in order to conduct phase III
studies.
• MIV-310 - HIV: Phase IIa results reported during summer. Planning for
phase IIb studies and seeking partnership in parallel.
• MIV-210 – Hepatitis B and HIV: Results from pre-clinical studies
reported at ICAAC in September. Ongoing phase I trails and planning for
phase IIa studies, both for Hepatitis B and HIV.
• (MV026048 – Licensed to Roche in April. Transfer of project completed
in June. Now in late pre-clinical development towards clinical trails
during 2003.)
Late Pre-clinical projects October 2002
CD
Project
NNRTI
-polymerase
inhibitor
HIV-protease
inhibitor
Indication
Hit
Identification
Lead
Identification
2000
HIV-AIDS
HIV-AIDS
Cathepsin S
-protease
inhibitor
e.g. astma, MS,
RA, GVHD
Cathepsin K
-protease
inhibitor
Osteoporosis
Lead
Optimisation
2002
Medivir’s strategy going forward
Strategy going forward 2003
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Mainly two internal clinical programs ongoing, MIV-310 and MIV-210.
The aim is to find partners for all clinical projects. The aim is to balance
risk/benefit in an optimal way.
Secure the Nordic rights in future partnerships.
Use CCS as a financial asset and develop it accordingly.
Continue aggressive “Key Account Management”.
Continue the focusing process in order to increase research capacity to speed
up several promising pre-clinical activities and projects.
Add pre-clinical collaborations and partners.
Add new targets.
Expand size and coverage of protease and polymerase inhibitor libraries by
building up of matrix metallo & serine protease inhibitor library.
Position Medivir as the preferred partner in protease and polymerase
research.
Medivir as an investment
”Well positioned for success and value creation”
• Medivir is one of the largest biotech companies in Europe in
terms of pipeline and personnel.
• Is establishing itself as the research driven small
pharmaceutical company. CCS is a strategic asset in this
process.
• Large scientific and commercial opportunities in pipeline.
• Solid financial position including opportunities in late stage
clinical projects.
• Existing and future partnerships will secure speed of
development adding value to the shareholders.
• Most likely to have one product to launch in 2005.